Automation Engineer

Our client is a medical device company developing innovative implantable cardiac technology. They operate in a regulated Class III environment and are led by a team with deep experience across device design, materials science, and commercial medical device development. The organization is at an exciting stage of growth, with a strong focus on advancing technology toward broader patient access.

The Manufacturing Automation Engineer designs, builds, and improves automated manufacturing equipment and tooling in a regulated Class III medical device environment. You will partner with Manufacturing Engineering and outside integrators to develop automated process equipment, write process instructions and equipment specifications, and drive quality and efficiency across the production floor.

• Design, program, and support automated manufacturing equipment from concept through end-of-life, including tooling and fixtures using best design practices
• Interface with outside suppliers and automation integrators to develop process equipment and tooling; support day-to-day manufacturing operations in a collaborative team environment
• Conduct qualification, verification, and validation activities (IQ/OQ/PQ) to support medical device production
• Analyze, troubleshoot, and resolve production issues relating to safety, efficacy, quality, cost, or delivery; interface with R&D, production supervisors, and engineers to optimize work design and product flow
• Provide manufacturing engineering support (change analysis, risk analysis, manufacturing readiness, new product development); drive improvements using Lean and Six Sigma

• BS in Engineering (Mechanical, Electrical, or related field)
• 5+ years designing automated medical device manufacturing tooling and equipment, or equivalent in a regulated industry
• Comprehensive knowledge of PLCs, motion control systems, and articulated robotic arms; ability to program to IEC 61131-3 standards
• Knowledge of Class III medical device manufacturing and 21 CFR 820, ISO 13485, and related standards
• Strong problem-solving, analytical, and critical thinking skills with good documentation practices
• Experience with Solid Works or other 3D CAD software (preferred)
• Good working knowledge of MS Office (Word, Excel, PowerPoint)

This is a mission-driven environment where the work carries direct patient impact. Contributions are high-stakes and visible, with strong exposure to advanced automation and novel manufacturing processes in a regulated medtech setting.